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ATHN 2: Factor Switching Study

NCT02546622 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 310

Last updated 2021-12-09

No results posted yet for this study

Summary

This is a longitudinal, observational study of patients with Hemophilia A or B who are planning to switch to a newly approved coagulation factor replacement product, or who have recently switched factor products. The study will follow each patient for up to 1 year. Patients will be recruited at Hemophilia Treatment Centers (HTC) which are ATHN-affiliates. The primary outcome being studied is the development of inhibitor (i.e., antibodies to factor) at 1 year or 50 exposure days, whichever comes first.

The study will be conducted at approximately 30 HTCs, with a planned enrollment of 600 patients.The entire study duration is projected to be approximately 6 years.

In addition, optional substudies will be included for some products, as "Product-Specific Modules". These will be questionnaires to collect data for subjects receiving selected Factor products. For example, subjects receiving Kovaltry will be approached to participate in the 'Kovaltry Product-Specific Module'; subjects receiving Adynovate will be approached to participate in the 'Adynovate Product-Specific Module'. Questions will be related to product use, perceptions of product use, and other post-marketing consumer data.

Conditions

Interventions

BIOLOGICAL

Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013

Prophylaxis for prevention of bleeding, various regimens.

BIOLOGICAL

Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013

Prophylaxis for prevention of bleeding, various regimens.

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • CSL Behring

    collaborator INDUSTRY

  • Bioverativ Therapeutics Inc.

    collaborator INDUSTRY

  • Bayer

    collaborator INDUSTRY

  • American Thrombosis and Hemostasis Network

    lead NETWORK

Principal Investigators

  • Ellis J Neufeld, MD, PhD · St. Jude Children's Research Hospital

  • Janna Journeycake, MD · Oklahoma Center for Bleeding and Clotting Disorders

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02546622 on ClinicalTrials.gov